International analysis and direct government involvement, two
phenomena that have been increasingly notable in the world of bioethics
in recent years, came together for a week in Rome this spring. From
April 10 to 15, the Italian government hosted the Fifth International
Summit Conference on Bioethic, which focused on the efforts now underway
to map and sequence the human genome. Originally proposed by Prime
Minister Nakasone, bioethics "summits" were inaugurated in
1984 when the first such meeting was held in Japan. That session on the
social impact of the new biological discoveries was followed by ones in
France on artificial fertilization, in Germany on the neurosciences and
society, and in Canada on human subjects research. It is expected that
sponsorship will continue to rotate through the Group of Seven, with
subsequent meetings in the United States and the United Kingdom, and
perhaps in Brussels as well under the sponsorship of the European
Economic Community (EEC), the summits' eighth participant.

Like its predecessors, the primary purpose of the Rome conference
was to provide advice to the heads of state of the seven major
industrial democracies at their annual summit meeting (held this year in
Toronto in June). Twenty-one national delegates, three representatives
from the EEC, one from the World Health Organization, and one from the
International Council of Scientific Unions joined summit chairman
Professor Glauco Tocchini-Valentini for the five-day meeting.

Six of the eight half-day sessions consisted of presentations by
the delegates--scientists, physicians, clerics, lawyers, and government
officials--on topics germane to their areas of expertise. These talks
not only made clear that the new knowledge of the human genome will
quickly generate momentous and complex ethical and social issues when
applied to predictive and curative medicine, but also that the prospect
of possessing this knowledge itself raises novel questions even as it
holds enormous fascination for scientists.

Indeed, the desirability and feasibility of an all-out scientific
effort to map and sequence the human genome have been hotly-debated for
the past several years. A National Research Council committee recently
urged that the United States immediately commence a fifteen-year program
at an estimated cost of $3 billion. The Department of Energy has
expressed interest in running such a project, while the National
Institutes of Health has moved to take leadership by budgeting
twenty-eight million dollars for the first year of such an effort.

The potential for both competition and collaboration is equally
pronounced on the international level. The science ministers of the EEC
nations have been debating establishing a cooperative European program
to match the U.S. initiative and the "human frontiers" program
recently launched by the Japanese. Some scientists fear that a crash
effort aimed at genome mapping will divert research funds from other,
more pressing objectives. They are also concerned it will prove more
costly (and no swifter) than a more measured approach that would build
on findings accumulated through investigations of particular genes and
on continuing rapid improvements in molecular genetic technology. Yet
the biomedical community seems not seriously to doubt that this massive
undertaking--mapping the 100,000 human genes to their usual locations on
the chromosomes and then establishing the actual sequence of the 3
billion nucleotide pairs that make up the genes and govern the
body's production of proteins--will eventually be completed and
will, among other things, prove of inestimable benefit in preventing and
treating disease.

The scientists at the Rome meeting were overwhelmingly supportive
of the research, and the delegates recommended that "concerted
national and international efforts should be undertaken through genetic
mapping, sequencing, and other research to allow for rapid generation
and dissemination of knowledge in this field." The delegates
firmly agreed that "there are no intrinsic limitations to the
acquisition of knowledge of the human genome and that research in this
area should be strongly encouraged." The view that ethical and
religious principles erect no a priori barriers to genetic knowledge is
consistent with the conclusion of the President's Commission in
Splicing Life, its 1982 report on human gene therapy, a copy of which
was given to each delegate.

Two of the other conclusions of the Rome meeting--classifying
somatic cell gene therapy with other medical experimentation, while
doubting that "medical indications [or] ethical
justifications" now exist for intentional manipulation of human
germ-line-cells--are also consistent with the conclusions of the
President's Commission and of such other U.S. committees as the
Humam Gene Therapy Subcommittee of NIH's Recombinant DNA Advisory
Committee, the major supervisory body for biomedical genetic engineering
in this country.

Other recommendations from Rome--that genetic information be
treated confidentially, that broad public education be provided, and
that countries rely on ethics commissions to develop and oversee policy
in this field--will likewise be familiar to Americans from Screening and
Counseling for Genetic Conditions, a 1983 report of the President's
Commission, which in turn reflected conclusions reached during the prior
decade by such groups as The Hastings Center and the NAtional Research
Council. [1] Looking to the future, the Rome delegates foresaw the need
for DNA banks for research purposes and the development of genetic
screening and disease-prevention methods, and suggested further
international examination of the "applicability and appropriateness
of patent and copyright law to the human genome."

That the recommendations were sensible rather than avant garde is
hardly surprising given the need for consensus across cultures, both
geographic and disciplinary. Still, the familiar ring of most of the
results in Rome may particularly disappoint Americans. Unlike most of
the topics at past summits (such as human subject research in 1987) that
had already been addressed by U.S. research groups, the ethics of gene
sequencing involved many novel issues. Particularly important are
questions of ownership and control of genetic information (only now
under study by the Office of Technology Assessment of the U.S. Congress)
and the implications of reverse genetics, that is, deciphering the
genetic basis of conditions and characteristics (not just disease) by
studying DNA variations before their biochemical manifestations have
been identified. Yet, beyond some rather general conclusions on gene
mapping and sequencing (including the old standby, "needs further
study"), most of the recommendations dealt not with this research
but with gene therapy, which has been rather thoroughly debated in the
U.S. already.

Nevertheless, the bioethics summits remain very significant.
First, they manifest concern at the highest levels of government with
bioethical issues. From its origins, bioethics has been characterized
by attention to the roles of persons and groups beyond physicians and
scientists in decisions about biomedical research and applications. Yet
during the first decade particularly, bioethical investigations were
largely the work of academics and of non-governmental research
organizations with little official support.

Recently government has been playing a larger role, at least in the
United States. Boards of various sorts have been chartered with
increasing frequency by the federal government, and have been joined by
local and state organizations such as the New York State Task Force on
Life and the Law and the New Jersey "bioethics commission."
Although the delegates to the Rome meeting did not speak for their
governments, the whole meeting--from the opening speeces at the Palazzo
del Quirinale by Italian President Francesco Cossiga and Minister of
Research Antonio Ruberti, to the drafting of the report to the Toronto
meeting of heads of state--was aimed at promoting responsible behavior
by governments as well as by the research community.

Second, the summits underline the need for greater international
consultation and collaboration in ethical analysis, as in scientific
research. Because bioethics implicates social, legal, and even
political factors that tend to be parochial rather than universal,
concepts and analysis (to say nothing of specific rules and
recommendations) will necessarily differ from country to country.
Nonetheless, comparative examinations of problems and potential
solutions can do much to shatter preconceived outcomes and to refresh
nationally based discussions that have become stale from the repetition
of familiar litanies.

References

[1] Marc Lappe, James M. Gustafon, and Richard Robin, "Ethical
and Social Issues in Screening for Genetic Disease," New England
Journal of Medicine 286:21 (1972), 1129-32; Committee for the Study of
Inborn Errors of Metabolism, National Research Council, Genetics
Screening: Programs, Principles, and Research (Washington, DC:: National
Academy of Sciences, 1975).

Alexander M. Capron, who holds the Norman Topping Chair in Law,
Medicine, and Public Policy at the University of Southern California,
was one of three U.S. delegates to the Rome meeting.

COPYRIGHT 1988 Hastings Center
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